Officially, Cindy Whitehead has moved on.

Whitehead is the entrepreneur who successfully disputed the U.S. Food and Drug Administration's initial denial of approval for Addyi, a drug designed to enhance female libido. After Addyi was approved, she sold Sprout Pharmaceuticals, the company she'd started to back Addyi, to Valeant Pharmaceuticals for $1 billion.

What followed is every entrepreneur's worst fear: The acquisition of Sprout, instead of giving a young company the resources and infrastructure it needed, landed it in purgatory. Sprout's deal closed Oct. 1; later that month, Valeant was accused of price gauging and fraud. Once valued at more than $260, Valeant stock fell to about $73 by mid-November and $35 by April; a new CEO was installed in April.

Whitehead left Valeant in December, saying she'd been promised the opportunity to run Sprout as a division of Valeant, but that Valeant had been centralizing its decision making during the crisis. "It didn't make sense for me to stay in this environment," she says.

On April 28, Whitehead announced that she had founded The Pink Ceiling, an investment company that will seed startups and work to commercialize products that solve problems of importance and interest to women. Whitehead, shown above with members of her Pink Ceiling team, says its first investment is Undercover Colors, which makes a nail polish designed to change colors in the presence of common date-rape drugs.

"I'm looking for something that's going to break through barriers with something that's very real, but will also open the door and potentially create an entire new category," she says.

Certainly, that was part of the attraction of Addyi, which pharmaceutical company Boehringer Ingelheim was essentially giving up on in 2011, after a negative evaluation from the FDA. "We got Addyi for nothing," says Whitehead. "The norm would have been to shop it around, but it was being put on the shelf." Instead, BI would get an equity stake if Addyi succeeded. To raise the money for the clinical trials she knew Addyi would need, Whitehead sold Slate Pharmaceuticals, which she had co-founded. The tests for Addyi would eventually cost about $50 million; Whitehead says she raised twice that. "Here I am, in a room full of grey or blue suits talking about sex,'" says Whitehead. "I would have to get past the giggles and the locker room jokes, so I would lead with the brain scans."

In 2013, the FDA denied regulatory approval for Addyi. Whitehead still wouldn't give up, and decided to formally dispute the decision. Through a PR campaign and lobbying effort, Sprout was able to convince the FDA to approve Addyi in August 2015. Sprout agreed not to advertise the drug for 18 months.

But after all that, by November 6, 2015, only 227 prescriptions for Addyi had been written. Whitehead says it's "too soon to tell" how successful Addyi will be, but she's clear that the description of Addyi as "the female Viagra" is not helping at all. Addyi affects brain chemistry, Whitehead points out, and has more in common with drugs such as anti-depressants than one meant to affect regional blood flow. "You don’t take an anti-depressant to feel euphoric," she says. "It's a subtle, nuanced thing."

Addyi also comes with an ominous warning telling women not to drink; women who want to take the pill have to sign a waiver promising that they will not consume alcohol. That itself would seem to account for the low take-up rate of the drug, but Whitehead says the acceptable threshold for casual drinkers is unknown, and that Valeant will be doing more tests to see if there is some safe level of alcohol consumption for women taking Addyi.

Addyi may yet have its day. Whitehead says Valeant will start marketing Addyi in the fall. There's no doubt that Whitehead will be rooting for the drug, just as she has for years--this time, from the sidelines.

 

 

Published on: Apr 29, 2016